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Trial registered on ANZCTR


Registration number
ACTRN12619000183189p
Ethics application status
Not yet submitted
Date submitted
5/02/2019
Date registered
8/02/2019
Date last updated
8/02/2019
Date data sharing statement initially provided
8/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of D-Mannose in patients with high risk of recurrent urinary tract infections
Scientific title
The effectiveness of D-Mannose in patients with high risk of recurrent urinary tract infections
Secondary ID [1] 297318 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infection 311390 0
Recurrent urinary tract infection 311391 0
Diabetes mellitus 311392 0
Condition category
Condition code
Renal and Urogenital 310024 310024 0 0
Other renal and urogenital disorders
Infection 310025 310025 0 0
Studies of infection and infectious agents
Metabolic and Endocrine 310065 310065 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is single dose of 2.5 grams of D-Mannose will be dissolved in water and drank every evening for 24 weeks.
Compliance: The allocated container holding the intervention will be weighed before being given to participants. Participants will be asked to return for six further follow-up appointments (one per month) with the research nurse and bring the same container with them. The container will be reweighed and documented. Comparison to baseline weight will be performed and estimate of dose taken in grams for monthly period will be calculated.



Intervention code [1] 313554 0
Prevention
Intervention code [2] 313555 0
Treatment: Drugs
Comparator / control treatment
The placebo is 2.5 grams of white powder (Guar gum) identical in appearance to D-Mannose to be dissolved in water and drank in the evening.
Control group
Placebo

Outcomes
Primary outcome [1] 318928 0
Percentage of patients developing a UTI in the trial period determined by urinalysis, clinical symptoms and micro culture.
Timepoint [1] 318928 0
Assessed at monthly followups (week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary outcome [1] 366456 0
Time (days) to urinary tract infection
Timepoint [1] 366456 0
Assessed at monthly followups (week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary outcome [2] 366457 0
Change in continence scores measured by BBUSQ
Timepoint [2] 366457 0
At baseline and week 24
Secondary outcome [3] 366458 0
Patient satisfaction with treatment measured on 0-10 VAS
Timepoint [3] 366458 0
Assessed at monthly followups (week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary outcome [4] 366459 0
Patient likelihood of continuing treatment measured on 0-10 VAS
Timepoint [4] 366459 0
Assessed at monthly followups (week 4, week 8, week 12, week 16, week 20 and week 24)
Secondary outcome [5] 366460 0
The effect of treatment on blood glucose management in diabetic patients . This will be measured by comparing before study blood levels of glycosolated Hb performed every second month via pathology and daily blood sugar levels (recorded by patients from finger prick) to levels taken during the study period. Both glycosolated Hb and daily blood sugar levels are part of standard clinical care.
Timepoint [5] 366460 0
Assessed every 2nd monthly visit (week 4, week 12, week 20 and week 24).

Eligibility
Key inclusion criteria
Female
Aged over 60 years
Diagnosed with diabetes mellitus
Adequate renal function as determined by treating medical officer
Diagnosed with recurrent UTI defined as 2 or more infections in 6 months or 3 or more infections in 12 months
Currently free of UTI (determined by absence of clinical symptoms)
Able to give valid consent
Available to attend a maximum of eight appointments at Sir Charles Gairdner Hospital.
Minimum age
60 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Current UTI or receiving treatment for UTI
Unable to give valid consent
Heavily dependent on medical care
Multiple co-morbidities (co-morbidities greater than 3 as determined by the Charlston Index)
Unable to attend appointments
Unable to read / write English
Unable to comply with study protocol

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be done by computer generated randomised spreadsheet that allocates the order of treatment / placebo to the participant. This will be administered by an independent person who is otherwise not involved in the research within the hospital pharmacy (clinical trials division).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random - computer generated allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analyses will consist of summary statistics expressed as mean and 95%CI for normally distributed continuous variables and frequencies and percentages for all categorical variables. Comparisons between categorical variables will be done using chi-square tests or Fisher exact test and Student t test for continuous variables. All data will be entered into SPSS (IBM Corp. Version 25). Relationships between demographic and clinical scores will be examined and OR calculated. Significance will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2019
Actual
Date of last participant enrolment
Anticipated
28/05/2021
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13050 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 25553 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 301864 0
Hospital
Name [1] 301864 0
Sir Charles Gairdner Hospital
Country [1] 301864 0
Australia
Funding source category [2] 301886 0
University
Name [2] 301886 0
Edith Cowan University
Country [2] 301886 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 301615 0
None
Name [1] 301615 0
Address [1] 301615 0
Country [1] 301615 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302558 0
North Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 302558 0
Ethics committee country [1] 302558 0
Australia
Date submitted for ethics approval [1] 302558 0
26/02/2019
Approval date [1] 302558 0
Ethics approval number [1] 302558 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90646 0
Dr Vicki Patton
Address 90646 0
Sir Charles Gairdner Hospital
Level 1 Harry Perkins Research Institute
Nedlands WA 6009
Country 90646 0
Australia
Phone 90646 0
+61 861510753
Fax 90646 0
+61 861510753
Email 90646 0
[email protected]
Contact person for public queries
Name 90647 0
Vicki Patton
Address 90647 0
Sir Charles Gairdner Hospital
Level 1 Harry Perkins research institute
Nedlands WA 6009
Country 90647 0
Australia
Phone 90647 0
+61 861510753
Fax 90647 0
+61 861510753
Email 90647 0
[email protected]
Contact person for scientific queries
Name 90648 0
Vicki Patton
Address 90648 0
Sir Charles Gairdner Hospital
Level 1 Harry Perkins research institute
Nedlands WA 6009
Country 90648 0
Australia
Phone 90648 0
+61 861510753
Fax 90648 0
+61 861510753
Email 90648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.